510(k) K962060 ยท GTZ Antisera, All Groups, Streptococcus Spp.
STREP A OIA MAX
| Applicant | Biostar, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | May 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2009 | Binax, Inc. dba IMPD Inverness Medical BioStar Strep A OIA MAX, 100 test kit size,
Product Code: 90003, in vitro diagnostic. Terminated |
GTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.